Trial document




drksid header

  DRKS00009620

Trial Description

start of 1:1-Block title

Title

The influence of flow pattern of minimized extracorporeal circulation on end organ function – measurement of microcirculation, endothelial function and hemodynamic energy.

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Minimized heart lung machines with reduced foreign surfaces and pulsatile flow may be beneficial to organ function as reduced foreign surfaces and pulsatile flow are shown to reduce complications during cardiac surgery and optimize organ function, respectively. It should be assessed on 50 patients whether a combination of both techniques within one heart lung machine can be effectively transferred into the human circulation, has positive effects on the capillary system and reduces inflammatory processes.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Although extracorporeal circulation (ECC) is associated with a low mortality around 1-3 % the morbidity is still high with 30 % and may lead to cardiac arrhythmias or reduced end organ function. Artificial surface mediated inflammatory response as well non physiological flow patterns are thought to be leading causes of morbidity.
Recent developed minimized system with reduced foreign surfaces and lower prime volume may reduce the still high morbidity and decrease arrhythmias and blood transfusions.
Due to myocardial infarction some patients requires aortic counterpulsation before cardiac surgery to optimize the myocardial oxygen delivery. Aortic counterpulsation during ECC has shown to be beneficial for end organ function.
New centrifugal pump based minimized ECC-system allows pulsatile flow without counterpulsation and thus may optimize end organ function not only in critically ill patients.
It should be investigated whether centrifugal based pulsatile flow can be effectively transferred into the circulatory system, is superior to continuous flow regarding hemodynamic energy and is beneficial to end organ function. Furthermore it should be assessed whether the flow pattern influences gut and buccal microcirculatory function as representative end organ regions.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00009620
  •   2015/12/04
  •   [---]*
  •   yes
  •   Approved
  •   24/15, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1176-1562 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I25.9 -  Chronic ischaemic heart disease, unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Coronary artery bypass grafting with continuous flow minimized extracorporeal circulation
  •   Coronary artery bypass grafting with pulsatile flow minimized extracorporeal circulation
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   data analyst
  •   Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Parallel
  •   III
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

1. intestinal and buccal blood flow and frequency
2. intestinal and buccal relative hemoglobin

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

1. Relative intestinal saturation
2. relative buccal Saturation
3. Endothelin I Expression
4. Energy equivalent pressure

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2015/12/09
  •   50
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Patient age > 18 years
Patient with coronary heart disease requiring bypass grafting with extracorporeal circulation
Calafiore blood cardioplegia
Written informed consent

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Ejection fraction < 20 %
Buckberg cardioplegia
Acute coronary syndrome less than 3days before surgery
Preoperative elevated inflammatory parameters (CRP > 10 mg/l or WBC > 12x109/l)
Malignant or immunological diseases

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Herz-, Kinderherz- und Gefäßchirurgie
    • Mr.  Prof. Dr. med  Andreas  Böning 
    • Rudolf Buchheim Str. 7
    • 35392  Gießen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Gießen und Marburg GmbHStandort GießenKlinik für Herz-, Kinderherz- und Gefäßchirurgie
    • Mr.  PGCert (London) BSc DipHSW (Open)  Johannes  Gehron 
    • Rudolf Buchheim Str. 7
    • 35392  Gießen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Herz-, Kinderherz- und Gefäßchirurgie
    • Mr.  Prof. Dr. med  Andreas  Böning 
    • Rudolf Buchheim Str. 7
    • 35392  Gießen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Klinik für Herz-, Kinderherz- und Gefäßchirurgie
    • Mr.  Prof. Dr. med  Andreas  Böning 
    • Rudolf Buchheim Str. 7
    • 35392  Gießen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.